Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2016-11-21
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study arm
Subcutaneous bortezomib 1.3mg/m2 on days 1, 4, 8, and 11 (every 4 weeks, up to 6 cycles) Oral thalidomide 50mg daily on days 1-28 (every 4 weeks, up to 6 cycles) Intravenous or oral dexamethasone 40mg on days 1-4 (every 4 weeks, up to 6 cycles)
Bortezomib
Six 4-week cycles
Interventions
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Bortezomib
Six 4-week cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma
* Previously untreated with chemotherapy
* ECOG performance status of 2 or lesser
* Peripheral blood white blood cell count ≥ 3,500/uL
* Peripheral blood neutrophil count ≥ 1,000/uL
* Peripheral blood platelet count ≥ 20,000/uL
* Peripheral blood hemoglobin ≥ 6.0g/dL
* Serum total bilirubin ≤ 2.0 mg/dL
* Serum aspartate aminotransferase ≤ 2.5 x (upper normal limit)
* Serum alanine aminotransferase ≤ 2.5 x (upper normal limit)
Exclusion Criteria
* Prior hematopoietic stem cell transplantation
* Prior organ transplantation
* Uncontrolled central nervous system involvement
* Congenital immunodeficiency
* Acquired immune deficiency syndrome (AIDS)
* Pregnancy
* Uncontrolled epilepsy
* Uncontrolled psychological disease
* Peripheral neuropathy of grade 3 or higher
19 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Youngil Koh
Assistant professor
Locations
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Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Yun-Jin Kim, CRC
Role: primary
Jeong-Ok Lee, MD
Role: backup
Eun-Hee Park, CRN
Role: primary
Junghoon Shin, MD
Role: backup
Other Identifiers
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1605-137-765
Identifier Type: -
Identifier Source: org_study_id